Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Young

ORCID ID

Contact details

Bradford Hospitals NHS Trust
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
+44 (0)1274 365 311

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PCC115

Study information

Scientific title

Acronym

Study hypothesis

The Second Bradford Community Stroke Trial seeks to assess the neglected area of psychosocial functioning in stroke patients and their families. Patients are randomly allocated to a control or intervention group. The latter group receive regular visits from one of the geriatric department liaison nurses who provide information, advice and support focusing on emotional and social recovery rather than physical function. Quantitative assessments are undertaken at 3, 6 and 12 months. However, there is a concern that the quantitative measures used may not be sufficiently comprehensive to capture the range of outcome experiences for the patient and carer. An additional qualitative evaluation would assess more fully the meanings and experience of their strokes for the patients in the two trial groups and thus facilitate:
1. A more detailed picture of the psycho-social difficulties experienced by stroke patients and their carers;
2. A better understanding of the nature of the intervention provided by the liaison nurses;
3. A more comprehensive evaluation of the trial outcome with a balance between quantitative and qualitative outcome assessments.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: Cerebrovascular disease

Intervention

1. Regular visits from one of the geriatric department liaison nurses who provide information, advice and support focusing on emotional and social recovery rather than physical function
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1994

Overall trial end date

09/06/1995

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing trabeculectomy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/1994

Recruitment end date

09/06/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Hospitals NHS Trust
Bradford
BD5 0NA
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes